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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intraventricular
510(k) Number K881493
Device Name PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.
Applicant
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact W NUMAINVILLE
Correspondent
Pharmacia Deltec, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact W NUMAINVILLE
Regulation Number882.5550
Classification Product Code
LKG  
Date Received04/08/1988
Decision Date 05/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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